The Principal Analyst, Statistical Programming leads and oversees statistical programming activities internally as well asexternally through vendors in theapplication of data standards, production of analysis datasets (ADaM), analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/she partners with Biostatistics to deliver high quality, submission ready statistical outputs.
Job Description :
This person is also responsible for providing input on overall study timeline, monitoring and meeting agreed upon study milestones, escalating issues as needed to their data management counterpart and estimating resources needs. He/she leads a study team of statistical programmers to accomplish tasks and communicate issues, as necessary, to senior management. This includes communication and quality oversight of the vendor. He/she is comfortable representing the Statistical Programming perspective to the study team and is often the sole functional representative.
The Principal Analyst, Statistical Programming helps to implement the Data Strategy, provides input to the Data strategy Lead on the strategic direction of the program, partners with the Data standards & governance Lead to ensure appropriate statistical programming standards implementation and serves as reference for the study to the Data sharing representatives. He/she develops and implements standard programming practices while also ensuring that they are employed across a study.
Principal Accountabilities: 1. Leads, coordinates and manages timely creation, oversight, review, completion, and delivery of statistical programming activities and deliverables of projects via internal and/or external staff oversight. 2. Authors CDISC SDTM and ADaM (analysis data model) analysis dataset specifications including the identification of potential data issues or areas of critical data examination. Works with statistics on defining and documenting programming endpoint algorithms 3. Manage the end-to-end programming of deliverables through from CRF collections through electronic submission including preparation of electronic submissions (ESUB) components (reviewers guides, annotated CRF, define and XPTs), ensures compliance to ESUB standards 4. Identifies process inefficiencies and lead efforts to remedy the inefficiencies and train the department on the new processes in conjunction with QPT. 5. Serves as the Statistical Programming Lead to achieve milestones for a study; evaluates task objectives, collaborates with DAL and/or manager on issues or resource needs. 6. Verifies program consistency and usage of data, analysis and submission standards across the department in conjunction with data standards and in consultation with the data strategy plan. 7. Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs.
* 10+ years relevant work experience within an organization with a focus on data management and analysis *10+ years SAS Base programming with 7+ years using SAS STAT, GRAPH and MACRO *10+ years relevant industry experience *10+ years clinical trial experience *7+ years clinical database experience *CDISC and/or submissions experience * Knowledge of drug development process and clinical trials * Knowledge of drug submission requirements, relevant ICH and FDA/EMEA/ROW guidelines * Familiarity with UNIX as well as software development packages (R, Imaging and Genomics software packages) * Management skills, and ability to effectively lead and collaborate across functions * Attention to detail including proven ability to manage some competing priorities
The Principal Analyst, Statistical Programming leads and oversees statistical programming activities of internally and externally through vendors in the in the application of data standards, production of analysis datasets, analysis dataset specifications, tables, listings, figures, electronic submission components (define.xml and XPTs), and ad hoc analyses. He/she partners with Biostatistics to deliver high quality, submission ready statistical outputs.